The Classification and Treatment of Myofascial Headache: a Cross-sectional Study and Randomized Controlled Trial.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Ghent
About this trial
This project comprises two studies; a cross-sectional study and a randomized controlled trial.
1. The goal of the cross-sectional study is to compare multiple outcome parameters in different headache types: tension type (TTH), cervicogenic (CGH) and myofascial headache (MFH) as drafted by the International Classification of Headache Disorders (ICHD). Not only will these types be compared against each other, they will also be compared to healthy controls (HC).
The main research questions are: * Are the criteria drafted by the International Classification of Headache Disorders (ICHD) discriminative for MFH? * Are there differences between the headache types (and healthy controls) in pain \& disability scores, range of motion (ROM), muscle strength, muscle elasticity and hyperalgesia (=pain pressure threshold, PPT)?
Participants will : * Fill out questionnaires about their pain and disability; * Be clinically investigated by a physiotherapist (anamnesis, inspection, examination of movement and structures of the neck and head); * Undergo a testing battery including neck ROM, neck muscle strength \& elasticity and PPT measurement of the C2 processus spinosus, the bilateral upper trapezius muscle and the tibialis anterior muscle of the dominant leg. 2. The goal of this randomized controlled study is to investigate the additional effect of dry needling in the treatment of MFH patients, as compared to a treatment consisting of manual techniques only. The main question it aims to answer is:
* Does manual therapy combined with dry needling provide an additional effect on pain, disability and functional outcomes in MFH patients, as compared to manual therapy alone?
After the baseline test (see part 1), participants with MFH will be randomly divided to receive 4 sessions over 4 weeks of MT or MT + DN. Hereafter, the baseline test is repeated at 1 week and 3 months post-treatment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
< 15 headache days per month
> 5 episodes of the headache that gives hindrance
Mean NPRS score for headache episodes >2/10
No history of whiplash
Disqualifiers
Diagnosis of migraine by a neurologist or as confirmed via the Headache Screening Questionnaire (HSQ) with the maximum score of 8/8.
Chronic headache (>15 headache days/month)
Newly onset headache (<5 previous episodes of new headache type)
Whiplash or whiplash associated disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Dry Needling
Other interventionDry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.
Manual therapy
Other interventionManual therapy comprises stretching of muscles, mobilizations, traction and translation of vertebrae, Sustained Natural Apophyseal Glides (SNAG), dynamic soft tissue mobilization, Muscle Energy Techniques (MET) and home-exercises.
Treatment groups
152 Participants
are divided into 2 treatment groupsGroup A: MT + DNExperimental treatment 2 interventions
Group B: MT aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Headache Disability Inventory (HDI)
The HDI is a 25-item questionnaire of which the questions focus on two categories. There are 13 questions related to the emotional effects and 12 questions on the functional effects of headache complaints. There are 3 answer options: yes (4 points), sometimes (2 points), no (0 points). The sum (maximum 100) gives an impression about the self-perceived limitations as a result of headache. The higher the score, the greater the hindrance caused by headache.
Time frame
Baseline; 1 week, 3 months, 6 months, 12 months post-treatmentSecondary outcomes
1
Neck Disability Index (NDI)
Changes in neck disability scores will be assessed by the Neck Disability Index. The Neck Disability Index consists of 10 questions, each with 6 answer options with concomitant scores ranging from 0 to 5, which makes the total score of the NDI on 50. A score between 5 and 14 represents a mild disability, whereas a score between 15 and 24 is interpreted as a moderate disability. NDI scores of 25 or higher reflect a severe disability.
Time frame
Baseline; 1 week, 3 months, 6 months, 12 months post-treatment2
Numeric Pain Rating Scale (NPRS)
Patient's neck pain and headache will be measured using an 11-point NRS, with a minimum value of zero ("no pain") and a maximum score of 10 ("the worst pain possible")
Time frame
Baseline; right before each treatment session; 1 week, 3 months, 6 months, 12 months post-treatment3
Range of Motion (ROM)
Using the EasyAngle device (Meloq Instruments), patients' neck ROM will be measured from a sitting position. Each movement (flexion, extension, bilateral lateral flexion and bilateral rotation) will be performed thrice. This will be done by the same researcher at every test moment.
Time frame
Baseline; 1 week and 3 months post-treatment4
Muscle strength (Fm)
Using the EasyForce device (Meloq Instruments), patients' neck muscle strength will be measured from a sitting position for lateral flexion (bilaterally) or from a supine or prone lying position for neck flexion and extension respectively. Three trials of 5 seconds of maximal force will be executed with 30 seconds rest between them. This will be guided by the same researcher at every test moment.
Time frame
Baseline; 1 week and 3 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov